Active Psoriatic Arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: ABY-035
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
CAS Number: 2226130-02-3
Current Sponsor code: ABY-035
Other descriptive name: Recombinant protein
Sponsors
Affibody AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient who has given his / her signed declaration of consent and data protection declaration 2. At least 18 years and less than 75 years of age at Screening visit 3. Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of =3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history. 4. Active psoriatic arthritis defined by: a. =3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit b. =3 tender joints out of 68 (TJC68) at Screening visit and Baseline visit 5. Precedent failure or insufficient treatment response or contraindication or intolerability to nonsteroidal antiphlogistic drug (NSAID) and / or DMARD (at least a, b or c of the following must apply): a. NSAID b. csDMARD (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A) c. TNFi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab) 6. Rheumatoid factor (RF) and anti-CCP antibody negative 7. Presence or history of plaque psoriasis 8. For females of childbearing potential only: Negative serum human chorionic gonadotropin (hCG) test at Screening visit 9. Willingness and capability of using adequate contraceptive methods from the Screening visit until 4 weeks after the last ABY-035 dose: a. Female of childbearing should use a highly efficient method of contraception (see 9c) but this is not necessary for females of non-childbearing potential permanently sterilized or post-menopausal [i.e. at least 12 consecutive months with amenorrhea without other known or suspected medical cause]) b. Male who has a female partner of childbearing potential, should use a highly efficient method of contraception (see 9c) c. Adequate contraceptive method defined as: i. A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner) OR ii. The use of two methods of contraception (e.g. one barrier method [condom, diaphragm or cervical / vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectables and implants]) 10. Willingness and capability of complying with all trial procedure requirements, as per the investigator’s judgement Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: Principal Exclusion criteria: 1. Underlying conditions which, in the investigator’s opinion, significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy 2. History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis 3. History of or current fibromyalgia or pain syndrome 4. Uncontrolled inflammatory bowel disease 5. Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit, e.g. due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections, that required medical / pharmaceutical intervention (i.e. prescription of antibiotics and / or hospitalization) 6. Clinically relevant Candida infection requiring systemic treatment within the last 6 months prior to Baseline visit 7. History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years (with the exception of basal cell or squamous cell carcinoma of the skin that had been fully excised with no evidence of recurrence) 8. Insufficiently controlled heart failure, as assessed by the investigator 9. Current uncontrolled arterial hyper- or hypotension Laboratory examinations and body measurements: 10. Positive test for subclinical / latent tuberculosis infection (i.e. positive QuantiFERON-TB® Gold test or equivalent product) or chest X-ray suggestive of tuberculosis at Screening visit 11. Positive test for human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) at Screening visit: a. HIV antibody (any test) b. HBV surface antigen (HBVsAg) c. Anti-HCV antibody (HCV Ab) 12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =2.5 times the upper limit of normal (ULN) at Screening visit 13. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 according to the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation at Screening visit 14. Body mass index (BMI) =40 kg/m2 or <16 kg/m2 Medication, drug use and special behavioral patterns 15. Previous exposure to ABY-035 or any other interleukin-(IL-)17i or IL-17 receptor inhibitor (e.g. secukinumab, ixekizumab, brodalumab) 16. History of hypersensitivity or allergy to ABY-035 or its excipients Refer to Protocol for full list of Exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of different dose regimens of ABY-035 as compared to placebo in patients with active psoriatic arthritis (PsA);Secondary Objective: To evaluate further efficacy, tolerability, safety, pharmacokinetics, immunogenicity and pharmacodynamics of two dose regimens of ABY-035;Primary end point(s): Primary Endpoint Family (Efficacy): ? ACR50 response rate at V9 (Week 16) for Higher Dose (80 mg) vs Placebo ? ACR50 response rate at V7 (Week 12) for Higher Dose vs Placebo;Timepoint(s) of evaluation of this end point: Primary Endpoint Family (Efficacy) evaluation Timepoint: ? ACR50 response rate at V9 (Week 16) for Higher Dose (80 mg) vs Placebo ? ACR50 response rate at V7 (Week 12) for Higher Dose vs Placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoint Family (Efficacy): ? ACR20/70 response rate at V9 (Week 16) ? ACR20/50/70 response rate at V5/V7/V13/FUEoT (Weeks 8/12/32/48) ? Proportion of patients achieving MDA at V9/V13/FUEoT (Weeks 16/32/48);Timepoint(s) of evaluation of this end point: Secondary Endpoint Family (Efficacy): ? ACR20/70 response rate at V9 (Week 16) ? ACR20/50/70 response rate at V5/V7/V13/FUEoT (Weeks 8/12/32/48) ? Proportion of patients achieving MDA at V9/V13/FUEoT (Weeks 16/32/48) | — |
Countries
Austria, Belgium, Czech Republic, Germany, Hungary, Poland, Spain
Contacts
Public ContactRegulatory Affairs
Affibody AB
Outcome results
None listed